SaberX Radianz R51005004LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032081679), received between Jun 23, 2023 and Feb 18, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 5MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED BEFORE REACHING NOMINAL PRESSURE. A 4MM X 4CM SABERX RADIANZ PTA BALLOON CATHETER WAS USED AS A REPLACEMENT TO PERFORM DILATION. AN UNKNOWN DRUG-COATED BALLOON (DCB) WAS THEN USED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A SUPERFICIAL FEMORAL ARTERY (SFA) PROCEDURE IN WHICH A RADIAL APPROACH WAS USED. AN UNKNOWN GUIDEWIRE WAS INSERTED PRIOR TO USE OF THE 5MM X 4CM SABERX RADIANZ PTYA BALLOON CATHETER. ADDITIONAL INFORMATION WAS REQUESTED BUT AS UNAVAILABLE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378266 ↗
• MalfunctionJan 22, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 5MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING ITS INITIAL DILATION TO NOMINAL PRESSURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A 90% STENOSED SUPERFICIAL FEMORAL ARTERY (SFA) LESION WHICH HAD SEVERE CALCIFICATION AND MILD TORTUOSITY. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WERE NO DIFFICULTIES REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18553031 ↗
• MalfunctionNov 14, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 5MM X 4CM 190CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING ITS INITIAL INFLATION TO 8 ATMOSPHERES (ATM). AS A RESULT, A DIFFERENT SIZED SABER PTA BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A LESION IN THE SUPERIOR FEMORAL ARTERY (SFA) WHICH HAD MILD CALCIFICATION AND MILD TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE BALLOON WAS ABLE TO MAINTAIN NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE IS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132580 ↗
• InjuryOct 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A RADIAL PERIPHERAL CASE, A 6F 110CM BRITE TIP RADIANZ SHEATH PROLAPSED INTO THE RIGHT ATRIUM AND COILED. THE PATIENT WAS BRIEFLY THROWN INTO AN ARRYTHMIA, BUT CORRECTED ONCE SYSTEM WAS PULLED OUT OF RIGHT ATRIUM. ONCE PROLAPSE WAS CORRECTED, IT WAS DISCOVERED THAT THE SABERX RADIANZ 5MM X 40MM BALLOON CATHETER WAS DIFFICULT TO PULL OFF THE .018 NON-CORDIS 300CM WIRE, THE BALLOON BROKE OFF AND FRACTURED UPON PULLING OUT. THE DISTAL TIP WITH RADIOPAQUE MARKERS WAS STILL ON THE GUIDEWIRE, WHICH WAS SNARED FROM A LEFT FEMORAL ACCESS POINT USING A NON-CORDIS SNARE. THE PROCEDURE WAS COMPLETED FROM A FEMORAL ACCESS POINT, WITHOUT PATIENT INJURY OR OTHER INCIDENTS WITH A CORDIS PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17939814 ↗
• InjuryJun 23, 2023Difficult to Remove; Difficult to Remove

  AS REPORTED A 5MM X 4 CM 190 SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATION CATHETER ¿WRAPPED AROUND THE WIRE AND CAUSED IT TO PROLAPSE AT THE SHEATHS TIP¿, WHICH CAUSED THE PTA NOT TO COME OUT. THERE WAS LACK OF A LONG SHEATH. THE PHYSICIAN NEEDED TO TAKE IT OUT IN THE OPERATING ROOM. THE PATIENT WAS NOT HARMED AND WAS DISCHARGED THE NEXT DAY. THE DEVICE WAS BEING USED TO TREAT A BYPASS GRAFT. THERE WAS NO LESION CALCIFICATION OR VESSEL TORTUOSITY WITH NINETY PERCENT (90%) STENOSIS. THE DEVICE WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER NOR DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY, MAINTAINING NEGATIVE PRESSURE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR CROSSING THE LESION. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17194799 ↗